BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 24760768 · Received April 1, 2026

    Report

    Report Number
    9681384-2026-00407
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    November 3, 2025
    Report Date
    April 1, 2026
    Manufacturer
    COVIDIEN AG JUAREZ (MMJ)
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: 6FEN, 6FEN 6 CUFF FEN TRACH CANN REUS ICX1, LOT# 25H0868JZX. 6FEN, 6FEN 6 CUFF FEN TRACH CANN REUS ICX1, LOT# 25H0868JZX. 6FEN, 6FEN 6 CUFF FEN TRACH CANN REUS ICX1, LOT# 25H0868JZX. 6FEN, 6FEN 6 CUFF FEN TRACH CANN REUS ICX1, LOT# 25H0868JZX. 6FEN, 6FEN 6 CUFF FEN TRACH CANN REUS ICX1, LOT# 25H0868JZX. 6FEN, 6FEN 6 CUFF FEN TRACH CANN REUS ICX1, LOT# 25H0868JZX. 6FEN, 6FEN 6 CUFF FEN TRACH CANN REUS ICX1, LOT# 25H0868JZX. 6FEN, 6FEN 6 CUFF FEN TRACH CANN REUS ICX1, LOT# 25H0868JZX. 6FEN, 6FEN 6 CUFF FEN TRACH CANN REUS ICX1, LOT# 25H0868JZX. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE LABELING HAD AN INCORRECT DESCRIPTION OF THE PRODUCT FROM THE TAG ATTACHED TO THE OTHER SIDE OF THE BOX. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819937 SHILEY TUBE TRACHEOSTOMY AND TUBE CUFF JOH COVIDIEN AG JUAREZ (MMJ) 6FEN 25H0868JZX

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE NOTES ON H11.